External Repository Documents

The External Repository Document module allows referencing external documents without storing them in the quality repository.

Overview

Use cases:

• ISO standards (ISO 9001, ISO 13485, etc.)
• Regulations (FDA, EU MDR, etc.)
• Pharmacopoeias
• ICH Guidelines
• Supplier documentation

Principle:

• Reference sheet in QDM with metadata
• Original document remains at its source
• URL link to official document

Main Features

• Reference an external document
• View external documents
• Correspondence tables

Main Fields

Field	Description
Title	Official document title
External reference	Official reference (e.g.: ISO 9001:2015)
Issuing organization	ISO, AFNOR, FDA, EMA, etc.
Type	Standard, Regulation, Guide, Pharmacopoeia
Access URL	Link to source site
Status	In force / Obsolete / Under revision

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See also:

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